510(k) Report

Devices descending from K002475

596 later devices reach Replace TPS Coated Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K112138Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc.2011200—
+5K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc.20110—
+5K110356Atlantis Crown Abutment, Atlantis Gemini +(TM) AbutmentAstra Tech, Inc.2011202—
+5K103759Atlantis Abutment in Zirconia for Osseospeed TX Profile ImplantAstra Tech, Inc.201119—
+5K100993Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsPrismatik Dentalcraft, Inc.201033—
+5K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+5K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+5K090174Tsi; EriOco Biomedical20094—
+5K071148Atlas Implant SystemCowellmedi Co., Ltd.20084—
+5K070562EZ Plus Implant SystemMegagen Co., Ltd.200774—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K241462LONGY Implant and LONGY-N ImplantNoris Medical, Ltd.20250—
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K213677Bonafix 2 PlusZentek Medical, LLC20220—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+6K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K213391High Retention Attachment SystemZest Anchors, LLC20227—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+6K212664SherlockOpen Implants, LLC20212—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K200386Z5-BLZ-Systems AG20200—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K190919ST Internal Implant SystemT-Plus Implant Tech. Co., Ltd.20200—
+6K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+6K181037DIO CAD/CAM AbutmentDio Corporation20187—
+6K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+6K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+6K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+6K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+6K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+6K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc.20160—
+6K1514553Shape Abutment Designer Software3Shape A/S201610—
+6K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+6K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+6K151375Inclusive Titanium Abutments compatible with: Hiossen HG Implant SystemPrismatik Dentalcraft, Inc.20150—
+6K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+6K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+6K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+6K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+6K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+6K142174Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20151—
+6K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+6K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+6K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+6K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+6K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+6K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+6K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+6K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+6K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+6K121810Osseospeed Angled Abutment EVAstra Tech AB20138—
+6K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+6K120043CSM Internal-R Implant SystemCsm Implant20121—
+6K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+6K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—